Leak detector for detecting leak of liquid injected into blood vessel using pulse signal

ABSTRACT

A leak detector sequentially emits pulse signals toward a human body at a position at which a needle is inserted, detects pulse signals reflected inside of the human body, and measures a time interval between the emission and the detection for each of the pulse signals. The leak detector then calculates the difference between the measured interval and a predetermined time interval, and generates a leak warning for notification when the difference exceeds an acceptable range. Since a swelling on the surface of the human body causes a path of the pulse signal to extend, the leak detector can detect, based on the extended signal path, that the needle has come off a blood vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a divisional of U.S. application Ser. No. 10/830,095, filed Apr.23, 2004, which issued as U.S. Pat. No. 7,546,776 on Jun. 16, 2009, andclaims the benefit of foreign priority under 35 U.S.C. §119 based onJapanese Application Nos. 2003-123460, 2003-378443, and 2004-046555,filed respectively on Apr. 28, 2003; Nov. 7, 2003; and Feb. 23, 2004,the entire disclosures of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a leak detector for detecting a leak oran extravasation of a liquid injected into a blood vessel near thesurface of a human body by a syringe, and more particularly, to a leakdetector for detecting a leak of a liquid injected by a liquid injector.

2. Description of the Related Art

Medical facilities currently used for imaging tomographic images of apatient include a CT (Computer Tomography) scanner, an MRI (MagneticResonance Imaging) apparatus, a PET (Positron Emission Tomography)apparatus, an ultrasonic diagnostic apparatus, and so on, and medicalfacilities currently used for imaging an angiogram of a patient includean angio apparatus, an MRA (MR Angio) apparatus, and so on. When amedical apparatus as listed above is used, a liquid such as a contrastmedium, a balanced saline solution, and the like may be injected into apatient. A liquid injector has also been brought into practical use forautomatically injecting a liquid. For example, the liquid injectoremploys a liquid syringe that is removably mounted, the liquid syringecomprises a cylinder member and a piston member slidably inserted in thecylinder member. The liquid injector has a syringe driving mechanismwhich presses the piston member into the cylinder member. The cylindermember, which is filled with a liquid, is coupled to a blood vessel nearthe surface of a human body through an extension tube and a needle, sothat that the liquid in the liquid syringe is force-fed into the bloodvessel of the human body by the liquid injector.

However, such a liquid injector automatically injects a liquid at a highpressure, so that even if the needle accidentally becomes detached fromthe blood vessel, for example, causing the liquid to leak under theskin, it is difficult for the operator to immediately recognize theleak.

To solve the problem as mentioned above, a variety of leak detectorshave been proposed for detecting a leak or an extravasation of a liquidinjected through a needle into a blood vessel of a human body, asdescribed, for example, in U.S. Pat. Nos. 6,408,204, 5,964,703,5,947,910, 6,375,624, 5,954,668, 5,334,141, 4,647,281, and 4,877,034.U.S. Pat. Nos. 6,408,204, 5,964,703, 5,947,910 disclose leak detectorsfor detecting a leaking liquid from a change in impedance on the surfaceof a human body; U.S. Pat. Nos. 6,375,624, 5,954,668, 5,334,141,4,647,281 disclose leak detectors for detecting a leaking liquid from achange in temperature of a human organ; and U.S. Pat. No. 4,877,034discloses a leak detector for detecting a leaking liquid from a changein optical characteristics of a blood.

However, all of these leak detectors have disadvantages of the need fora special sensor, a complicated structure, and a significant degradationin detection accuracy caused by disturbance.

SUMMARY OF THE INVENTION

The present invention has been made in view of the problem as mentionedabove, and it is an object of the invention to provide a leak detectorwhich is simple in structure and minimizes a degradation in detectionaccuracy due to disturbance.

A first leak detector according to the present invention is provided fordetecting a leak of a liquid injected through a needle into a bloodvessel near the surface of a human body, and includes pulse generatingmeans, pulse detecting means, interval measuring means, differencecalculating means, difference comparing means, and leak warning means.The pulse generating means sequentially emits pulse signals through wavepropagation at a predetermined wavelength into the human body at aposition at which the needle is inserted. The pulse detecting meansdetects pulse signals reflected inside of the human body. The intervalmeasuring means measures a time interval between the emission and thedetection for each of the pulses, and the difference calculating meanscalculates the difference between the measured time interval and apredetermined reference time interval. The difference comparing meanscompares the calculated difference with a predetermined acceptablerange, and the leak warning means generates a leak warning fornotification when the difference exceeds the acceptable range.

With the foregoing configuration in the first leak detector of thepresent invention, as the human body swells out on the surface due to aliquid leaking from a needle which has come off a blood vessel, theswelling causes a change in distance and time interval between theemission and the detection of the pulse signals reflected inside of thehuman body, so that the leak detector detects a leak of the liquidmaking use of the change in interval. With this approach, the accuracyof the detection is hardly degraded due to disturbance, and only asimple structure is required for the detection.

A second leak detector according to the present invention includeswavelength measuring means instead of the interval measuring means,wherein the wavelength measuring means measures the wavelength of adetected pulse signal, and the difference calculating means calculatesthe difference between the measured wavelength and a predeterminedreference wavelength. Therefore, in the second leak detector of thepresent invention, as the human body swells out on the surface due to aliquid leaking from a needle which has come off a blood vessel, theswelling causes a change in wavelength of the wave propagation reflectedinside the human body, so that the leak detector detects a leak of theliquid making use of the change in wavelength. With this approach, theaccuracy of the detection is hardly degraded due to disturbance, andonly a simple structure is required for the detection.

It should be noted that a variety of means referred to in the presentinvention are only required to be formed to implement functionsassociated therewith, and can be implemented, for example, by dedicatedhardware for performing predetermined functions, a data processorprovided with predetermined functions through a computer program,predetermined functions implemented by a data processor through acomputer program, a combination of these, and the like.

Also, a variety of means referred to in the present invention need notbe individually independent components, but may include a plurality ofmeans formed into a single member, certain means included in anothermeans as part thereof, part of certain means overlapping with part ofanother means, and the like.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram illustrating the logical structure of aliquid injector according to one embodiment of the present invention;

FIG. 2 is a block diagram illustrating the physical structure of theliquid injector;

FIG. 3 is a perspective view illustrating the outer appearance of theliquid injector;

FIGS. 4 a and 4 b are perspective views illustrating how a liquidsyringe is mounted on an injection head;

FIG. 5 is a perspective view illustrating the outer appearance of an MRIapparatus;

FIG. 6 is a front longitudinal sectional view illustrating a leakdetection unit;

FIG. 7 is a perspective view illustrating how the leak detection unit ismounted on an arm of a human;

FIG. 8 is a flow chart illustrating the processing operation of the leakdetection unit;

FIG. 9 is a flow chart illustrating a main routine of the processingoperation of an injector body;

FIG. 10 is a flow chart illustrating a subroutine of an injectionprocess;

FIGS. 11 a and 11 b are schematic diagrams illustrating how an armswells out with the leak detection unit mounted on the surface thereof;

FIGS. 12 a and 12 b are perspective views each illustrating an exemplarymodification to the leak detection unit;

FIG. 13 is a perspective view illustrating how the leak detection unitis mounted onto an arm using a modified adhesive pad;

FIG. 14 is a perspective view illustrating how the leak detection unitis mounted onto an arm using another modified adhesive pad;

FIG. 15 is a perspective view illustrating another exemplarymodification to the leak detection unit;

FIG. 16 is a schematic front view illustrating a display screen whichdisplays a trend graph representing time intervals measured forrespective pulse signals; and

FIG. 17 is a schematic front view illustrating a display screen whichdisplays a trend graph representing time intervals measured forrespective pulse signals.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Configuration ofEmbodiment

One embodiment of the present invention will hereinafter be describedwith reference to the accompanying drawings. It should be first notedthat in the following embodiment, front, rear, left, right, upward, anddownward directions are defined as illustrated for description, but suchdefinition of the directions is conveniently made for simplifying thedescription, and is not at all intended to limit the apparatus of thepresent invention to such directions during manufacturing, in use, andso forth.

Referring to FIG. 3, liquid injector 100 of this embodiment comprisesinjector body 101; operation panel 102 and liquid crystal display 103provided on the top surface of injector body 101; and injection head 110supported by a movable arm 104 on one side of injector body 101. asshown in FIG. 4, injection head 110 is formed with recess 112 which hasthe shape of a semi-cylindrical groove, such that liquid syringe 200 isremovably fitted in recess 112.

Liquid syringe 200 comprises cylinder member 201 and piston member 202,where piston member 202 is slidably inserted into cylinder member 201.Cylinder member 201 is formed with cylinder flange 203 around the outerperiphery of the distal end thereof, while piston member 202 is formedwith piston flange 204 around the outer periphery of the distal endthereof.

In liquid injector 100 of this embodiment, liquid cylinder 200 held ininjection head 110 is coupled to blood vessel 501 in arm 500 of a humanbody through extension tube 211 and needle 212, and needle 212 is heldby adhesive pad 213 made of a transparent sheet which is highlytransparent to infrared rays, for example, as can be seen in FIG. 7.

Injection head 110 has piston driving mechanism 113 disposed behindrecess 112 of syringe holder member 111 for holding and movingback-and-forth piston flange 204. Specifically, piston driving mechanism113 contains driving motor 115 and empty sensor 116, as shown in FIG. 2,and actuates with driving motor 115 which acts as a power source. Emptysensor 116 in turn detects piston flange 204 at a particular position tosense that liquid syringe 200 has completely injected a liquid.

In this embodiment, liquid injector 100 is formed integrally with a leakdetector, wherein injector body 101 also serves as a detector body.Thus, leak detection unit 401 is formed separately from injector body101, and makes radio communications with injector body 101.

More specifically, leak detection unit 401 has a flat box-shaped unithousing 402, as shown in FIG. 7, and contains photodiode 403 whichrepresents a pulse generating means, and photo-transistor 404 whichrepresents a pulse detecting means within unit housing 402. Photodiode403 and photo-transistor 404 are oriented downward in unit housing 402,as can be seen in FIG. 6.

Photodiode 403 emits infrared rays at a predetermined wavelengthdownward as wave propagation, while photo-transistor 404 receives theinfrared rays at that wavelength from below. Optical filter 406, whichpasses therethrough only the infrared rays at the predeterminedwavelength, is disposed at a position opposite to and below thesephotodiode/photo-transistor 403, 404. The infrared rays are set at awavelength at which they transmit through particular organs of a humanbody, and are reflected by particular organs. For example, the infraredrays at the set wavelength are highly penetrative through skin and fat,but is highly reflective to muscles.

Circuit board 407 is disposed in an upper region within leak detectionunit 401, and has mounted thereon photodiode/photo-transistor 403, 404,central processing circuit 408, and radio transmission unit 409,respectively.

Central processing circuit 408 is in wired connection withphotodiode/photo-transistor 403, 404 as well as with radio transmissionunit 409 for forcing photodiode 403 to sequentially emit pulse signalsand for detecting the pulse signals from the output of photo-transistor404.

Also, central processing circuit 408, which comprises logic circuits ina predetermined structure, has a variety of hardware components whichfunction as interval measuring circuit 411, interval storing circuit412, difference calculating circuit 413, and difference comparingcircuit 414.

Interval measuring circuit 411, which comprises, for example, a countercircuit or the like, measures a time interval between emission anddetection of each of the pulse signals.

Interval storing circuit 412, which comprises, for example, a FIFO(First In First Out) memory or the like, stores a measured time intervaluntil the next time interval is measured.

Difference calculating circuit 413, which comprises, for example, asubtract circuit or the like, calculates the difference between the lastmeasured time interval, as a reference time interval, and the currentlymeasured time interval.

Difference comparing circuit 414, which comprises, for example, acomparator circuit or the like, compares the calculated difference witha predetermined acceptable range.

Then, when the difference does not exceed the acceptable range, centralprocessing circuit 408 instructs radio transmission unit 409 to transmita predetermined standby signal at all times through radiowaves. As thedifference exceeds the acceptable range, central processing circuit 408instructs radio transmission unit 409 to transmit a predeterminedwarning signal over the air.

Referring back to injector body 101, which contains microprocessor 130as shown in FIG. 2, microprocessor 130 is in wired connection withoperation panel 102, liquid crystal display 103, driving motor 115,empty sensor 116, radio reception unit 131, speaker unit 132, and thelike.

Microprocessor 130, which comprises a so-called one-chip microcomputer,has appropriate computer programs installed in the form of firmware orthe like. Microprocessor 130 totally controls the foregoing respectivecomponents in accordance with the computer programs, thus allowingliquid injector 100 of this embodiment to logically have a variety offunctions including leak warning function 141, reception detectingfunction 142, state informing function 143, reception warning function144, and injection suspending function 146, as shown in FIG. 1.

Leak warning function 141 represents a function of microprocessor 130for controlling the operation of speaker unit 132 and liquid crystaldisplay 103 in accordance with a computer program. Specifically, as astandby signal received by radio reception unit 131 over the air isswitched to a warning signal, leak warning function 141 generates a leakwarning audibly from speaker unit 132 and visually from liquid crystaldisplay 103 for notification to the operator.

Reception detecting function 142 represents a function of microprocessor130 for detecting the operating state of radio reception unit 131.Specifically, microprocessor 130 detects the receiving state of radiosignals. State informing function 143 represents a function ofmicroprocessor 130 for controlling the operation of liquid crystaldisplay 103. Specifically, microprocessor 130 informs a receiving statedetected by reception detecting function 142 in the form of an imagedisplayed on liquid crystal display 103.

Reception warning function 144 also represents a function ofmicroprocessor 130 for controlling the operation of speaker unit 132 andliquid crystal display 103. Specifically, as the receiving statedetected by reception detecting function 142 falls below a predeterminedstate, microprocessor 130 generates a reception warning audibly fromspeaker unit 132 and visually on liquid crystal display 103 fornotification to the operator.

Injection suspending function 146 represents a function ofmicroprocessor 130 for controlling the operation of driving motor 115 ofpiston driving mechanism 113. Specifically, microprocessor 130,responsive to at least one of a leak warning and a reception warning,stops driving motor 115 to suspend the injection of a liquid.

A variety of foregoing functions 141-146 of liquid injector 100 asmentioned above are implemented using hardware such as speaker unit 132and the like as required, but are essentially implemented bymicroprocessor 130 which runs in accordance with computer programsinstalled therein.

Such computer programs are described to cause microprocessor 130 toexecute processing operations, for example, instructing speaker unit 132and liquid crystal display 103 to generate a leak warning fornotification in response to a warning signal received by radio receptionunit 131 over the air; instructing driving motor 115 in association withthe generation of the leak warning; detecting the receiving state ofradio reception unit 131; displaying the receiving state on liquidcrystal display 103 for notification; instructing speaker unit 132 andliquid crystal display 103 to generate a reception warning fornotification in response to the receiving state falling below apredetermined state; stopping driving motor 115 in association with thegeneration of the reception warning, and so on.

As illustrated in FIG. 5, liquid injector 100 of this embodiment isused, for example, near imager unit 301 of MRI apparatus 300, and may beconnected to control unit 302 of MRI apparatus 300 as required. Controlunit 302, which comprises a computer system that has detector body 303,liquid crystal display 304, and keyboard 305, controls the operation ofimager unit 301, and displays a tomographic image on liquid crystaldisplay 304.

For simplifying the illustration in FIG. 5, both liquid injector 100 andcontrol unit 302 are positioned near imager unit 301, whereas in anactual medical field, liquid injector 100 alone is typically disposednear imager unit 301, with control unit 302 being installed in adifferent room.

Operation of Embodiment

In the configuration as described above, when liquid injector 100 ofthis embodiment is used, for example, the operator couples needle 212through extension tube 211 to liquid syringe 200 filled with a liquidsuch as a contrast agent, and inserts needle 212 into blood vessel 501in arm 500 of a patient positioned in imager unit 301 of MRI apparatus300, as shown in FIG. 7, using adhesive pad 213 for holding needle 212on arm 500.

Next, leak detection unit 401 is mounted on adhesive pad 213 with abinding belt (not shown), and liquid syringe 200 is loaded intoinjection head 10 of liquid injector 100. In such a state, leakdetection unit 401 and injector body 101 are each powered on, followedby a predetermined manipulation to set injector body 101 into anoperation mode for using leak detection unit 401.

In response, leak detection unit 401 sequentially emits infrared pulsesignals from photodiode 403 toward a position of arm 500 at which needle212 is coupled (step S1), as shown in FIG. 8. However, as shown in FIG.11, the infrared pulse signals are highly penetrative through particularorgans of human and are highly reflective to other particular organs,thus permitting photo-transistor 404 to detect such reflected pulsesignals (step S3).

In this event, a time interval is measured between the emission and thedetection of each pulse (steps S1-S4), and the measured interval is held(step S5). Simultaneously, the last measured interval is referenced tocalculate the difference between the currently measured interval and thelast measured interval (step S6), followed by a determination which ismade as to whether or not the difference exceeds an acceptable range(step S7).

Then, leak detection unit 401 transmits a standby signal indicative of“normal” to injector body 101 over the air if the difference does notexceed the acceptable range (step S8), and transmits a warning signalindicative of “anomalous” if the difference exceeds the acceptable range(step S9).

For example, if needle 212 becomes detached from blood vessel 501 in arm500, into which it has been inserted, as shown in FIG. 7, a liquid willnot be injected into blood vessel 501 but into its surroundings to swellarm 500 out, as can be seen on the surface of the skin as shown in FIG.11 b. Consequently, the pulse signal emitted from photodiode 403 isreflected within swelling arm 500, causing a path to extend until thepulse signal is detected by photo-transistor 404, as appreciated fromFIGS. 11 a and 11 b.

In this event, since the measured interval between the reflection andthe detection for the pulse signal is increased, this increase iscalculated as the difference between the last and currently measuredintervals. As this difference exceeding the predetermined acceptablerange will cause radio transmission unit 409 to transmit the warningsignal over the air, the swelling skin surface results in radiotransmission of the warning signal.

When injector body 101 is operating using leak detection unit 401,injector body 101 detects the receiving state of the radiowaves at alltimes (step T1), and displays the receiving state on liquid crystaldisplay 103 in the form of bar graph or the like in real time (step T2),as shown in FIG. 9.

With the foregoing operation, the operator can confirm the receivingstate of the radiowaves from leak detection unit 401 in real time whileoperating injector body 101, and will adjust the position of injectorbody 101 and leak detection unit 401 if the receiving state is notproper.

Also, as the receiving state detected as mentioned above falls below thepredetermined state (step T3), injector body 101 displays a receptionwarning such as “RADIOWAVES CANNOT BE RECEIVED. CONFIRM COMMUNICATIONSTATE.” on liquid crystal display 103, and audibly generates thereception warning from speaker unit 132 (step T4).

In this event, since injector body 101 does not accept any inputoperation for resuming the injection until the receiving state from leakdetection unit 401 ameliorates (steps T3-T5), injector body 101 does notstart the liquid injecting operation unless a proper receiving state isrecovered (step T6).

Further, when injector body 101 accepts an input operation for startingthe injection of a liquid (steps T5, T6), injector body 101 stilldetects the receiving state of radiowaves at all times for display onliquid crystal display 103 in real time (steps E1, E2).

Then, as the detected receiving state falls below the predeterminedstate, injector body 101 generates a reception warning visually fromliquid crystal display 103 and audibly from speaker unit 132 fornotification to the operator (steps E3, E4), and does not perform theliquid injecting operation unless the receiving state is determined asproper.

When the injecting operation is in progress with a proper receivingstate (step E6), injector body 101 is responsive to a change from thestandby signal, received thereby over the air, to a warning signal (stepE7) so as to display a leak warning such as “NEEDLE IS DETECTED TO COMEOFF. CONFIRM NEEDLE” on liquid crystal display 103, and to audiblygenerate the leak warning from speaker unit 132 (step E8).

In this event, since the liquid injecting operation is suspended (stepE9), the liquid will not be continuously injected while needle 212remains off blood vessel 501. Further, since the leak warning iscontinuously generated for notification until a predetermine resetoperation is performed on injector body 101 (steps E10, E11), theoperator will confirm the leak warning without overlooking it.

In liquid injector 100 of this embodiment, as the operator, who hasconfirmed the leak warning, appropriately inserts needle 212 into bloodvessel 501 and then operates on operation panel 102 to start injectingthe liquid, liquid injector 100 can resume injecting the liquid inresponse to the operation (steps T5, T6).

Also, when the operator operates on operation panel 102 to suspend theinjection (step E12), injector body 101 likewise suspends the injectionof the liquid (step E9). Further, when empty sensor 116 detects that theinjection of the liquid is completed (step E13), injector body 101finishes the injection of the liquid (step E14).

Effects of Embodiment

Liquid injector 100 of the foregoing embodiment sequentially emitsinfrared pulse signals toward a position of arm 500 at which needle 212is inserted, and detects those pulse signals which are reflected withinarm 500, as described above. Then, liquid injector 100 calculates thedifference between a time interval between the emission and thedetection, measured for each pulse signal, and a reference timeinterval, and generates a leak warning for notification if thedifference exceeds a predetermined acceptable range.

With the foregoing approach, when needle 212 becomes detached from bloodvessel 501 to leak or extravasation a liquid which causes arm 500 of thehuman body to swell out on the surface, liquid injector 100 generates aleak warning, thereby permitting the operator to immediately recognizethat needle 212 has come off blood vessel 501 of the patient for takingappropriate actions thereto.

Moreover, upon detection of needle 212 which has come off blood vessel501, liquid injector 100 of this embodiment automatically suspends theinjection of the liquid, making it possible to automatically prevent theliquid from being continuously injected with needle 212 remaining offblood vessel 501.

Further, as described above, since liquid injector 100 of thisembodiment relies on a swelling recognized on a skin surface to detectthat needle 212 has come off blood vessel 501, and relies on a change inthe path length of infrared rays reflected from a human organ to detectthe swelling on the skin surface, liquid injector 100 can detect aleaking liquid in a simple structure without substantially sufferingfrom a degraded accuracy due to disturbance.

Furthermore, liquid injector 100 of this embodiment stores a timeinterval measured between the emission and the detection of each pulseat least until the next measurement, and calculates the differencebetween the currently measured interval and the last measured intervalwhich is used as a reference time interval. This way of calculating thedifference eliminates the need for previously setting an appropriatereference time interval, enabling liquid injector to successfully detecta change in position of a skin surface irrespective of whichever site ofhuman body to be monitored, personal differences in skinfold thickness,and the like.

Further, since photodiode 403 emits infrared pulse signals at awavelength which transmit through particular organs in arm 500 of thehuman body and are reflected by other particular organs, the pulsesignals can be made to transmit through the surface of the human bodyand to be reflected from a particular organ. Moreover, since opticalfilter 406 passes the infrared rays only at that wavelength therethroughto photo-transistor 404, it is possible to prevent photo-transistor 404from erroneously detecting surrounding light noise.

Further, liquid injector 100 of this embodiment comprises leak detectionunit 401 which contains photodiode 403, photo-transistor 404, radiotransmission unit 409, and the like separately from injector body 101which contains radio reception unit 131, liquid crystal display 103,speaker unit 132, and the like.

Then, as leak detection unit 401 detects a swelling on a skin, injectorbody 101 generates a leak warning for notification through radiocommunication, leak detection unit 401, which is mounted directly on ahuman body, can be reduced in size and weight for facilitating itshandling. Even with such a smaller and lighter configuration, leakdetection unit 401 can ensure that a leak warning is recognized by theoperator who is manually operating injector body 101 remotely from leakdetection unit 401.

Moreover, injector body 101 detects at all times a receiving state of aradio signal from leak detection unit 401 to inform the receiving statein real time. This permits the operator to recognize at all times acommunicating state between leak detection unit 401 and injector body101, and to take an appropriate action to an improper communicatingstate, if any, before the injection is started.

Further, since injector body 101 generates a reception warning fornotification if a detected receiving state falls below a predeterminedstate, liquid injector 100 can prevent a failure in receiving thewarning signal due to a faulty communication, and a resulting failure ingenerating the leak warning. In addition, since liquid injector 100suspends the liquid injection if even one of the leak warning andreception warning is generated for notification, liquid injector 100 cannot only automatically prevent a liquid from being continuously injectedwhile needle 212 remains off blood vessel 501 but also prevent theliquid from being continuously injected while it remains incapable ofreceiving the warning signal over the air.

Exemplary Modifications to Embodiment

It should be understood that the present invention is not limited to theforegoing embodiment but may be modified in various ways withoutdeparting from the spirit and scope of the invention. For example, whilethe foregoing embodiment has illustrated liquid injector 100 integratedwith leak detection unit 401, leak detection unit 401 may be formedseparately from liquid injector 100.

Nevertheless, liquid injector 100 is advantageously integrated with leakdetection unit 401 because the injection of a liquid must be immediatelysuspended upon detection of a leak or an extravasation of the liquid, asdescribed above. Therefore, when leak detection unit 401 is formedseparately from liquid injector 100, liquid injector 100 is preferablyconfigured to suspend the injection in response to a warning generatedby leak detection unit 401.

Further, while the foregoing embodiment has illustrated that liquidinjector 100 generates a leak warning and a reception warning fornotification, such warnings may be transmitted to control unit 302 ofMRI apparatus 300 to display the warnings on liquid crystal display 304for visual notification. As previously described, since control unit 302is installed at a location remote from imager unit 301, the warnings arebeneficially communicated to imager unit 301.

Also, while the foregoing embodiment has illustrated that liquidinjector 100 suspends the injection in response to a leak warning, MRIapparatus 300 can also stop imaging in association with such a suspendedoperation of liquid injector 100. In this event, liquid injector 100 cantransmit the warning signal from leak detection unit 401 directly to MRIapparatus 300, or alternatively can transmit the warning signalindirectly from injector body 101.

While the foregoing embodiment has been illustrated on the assumptionthat liquid injector 100 is used near MRI apparatus 300, liquid injector100 may be used near a CT scanner, a PET apparatus, an angio apparatus,an MRA apparatus, an ultrasonic diagnosis apparatus, and so on.

Further, while the foregoing embodiment has illustrated that leakdetection unit 401 makes radio communications with injector body 101through radiowave signals, liquid injector 100 can employ anycommunication scheme, including an ultrasonic signal based wirelesscommunication, an optical signal based wireless communication, anelectric signal based wired communication, an optical signal based wiredcommunication, and so on.

Also, while the foregoing embodiment has illustrated that leak detectionunit 401 emits infrared pulse signals to a human body, detects thoseinfrared pulse signals reflected from the human body, and calculates thedifference between a measured time interval between the emission and thedetection for each pulse signal and a reference time interval which isthe last measured interval, the first measured interval may be definedas the reference interval.

Further, the foregoing embodiment has illustrated that the infraredpulse signals transmit through particular organs of a human body and arereflected by other particular organs, so that leak detection unit 401detects that needle 212 has come off blood vessel 501, taking advantageof the fact that a swelling skin surface due to a leaking liquid causesa change in time interval between the emission and the detection of theinfrared pulse signal.

However, when the infrared rays transmit through particular organs of ahuman body and are reflected by other particular organs, a liquidleaking into one of the reflective organs causes a change in wavelengthof the reflected infrared rays. Bearing this in mind, leak detectionunit 401 can detect that needle 212 has come off blood vessel 501 bymeasuring the wavelength of detected infrared rays, and comparing themeasured wavelength with a predetermined reference wavelength. In thisevent, the last measured wavelength may be used likewise as a referencewavelength, or the first measured wavelength may be used as thereference wavelength.

Also, while the foregoing embodiment has illustrated that photodiode 403is used as a pulse generating means for generating infrared pulsesignals, and photo-transistor 404 is used as a pulse detecting means fordetecting the infrared pulse signals, photodiode 403 may be replaced,for example, with an ultrasonic vibrator (not shown) for transmittingultrasonic pulse signals for use as the pulse generating means, andphoto-transistor 404 may be replaced with an ultrasonic detector device(not shown) for detecting ultrasonic pulse signals for use as the pulsedetecting means. Since the resulting leak detector (not shown) canultrasonically detect a leak or an extravasation of a liquid, it is notaffected by surrounding light rays in the detection.

Further, while the foregoing embodiment has illustrated that leakdetection unit 401 is mounted with one each of photodiode 403 andphoto-transistor 404, leak detection unit 401 may be replaced with leakdetection unit 421 having a plurality of photodiodes 403 and a pluralityof photo-transistors 404 arranged in matrix as shown in FIG. 12 a, orwith leak detection unit 422 having a plurality of photo-transistor 404arranged around single photodiode 403 as shown in FIG. 12 b. Since theresulting leak detector can detect a leaking liquid at a plurality ofsites, it can detect a leaking liquid at an exact site.

Also, while the foregoing embodiment has shown adhesive pad 213 made ofa simple transparent sheet for holding needle 212 and for adhering leakdetection unit 401 on arm 500, adhesive pad 221 made of a transparentsheet may be provided with printed marks 222, 223 for representing thepositions of needle 212 and leak detection unit 401.

In this event, needle 212 and leak detection unit 401 can be placed inan appropriate positional relationship by aligning needle 212 and leakdetection unit 401 to respective associated printed marks 222, 223 onadhesive pad 221, permitting leak detection unit 401 to readily detect aleaking liquid without fail.

Optionally, as shown in FIG. 14, adhesive pad 226 may be formed in a bagshape to serve as a protection member, such that leak detection unit 401can be enclosed in adhesive pad 226. In this event, since leak detectionunit 401 can be prevented from damages and contaminations by adhesivepad 226 which is a replaceable consumable item, leak detection unit 401can be readily disinfected.

Also, as shown in FIG. 15, leak detection unit 431 may be formed to besufficiently small, with CCD (Charge Coupled Device) camera 432supported by an arm 433 above leak detection unit 431 for use as animaging means. In this configuration, since CCD camera 432 captures animage around leak detection unit 431, the captured image is wirelesslytransmitted to liquid injector 100 for display on liquid crystal display103.

With the foregoing approach, the operator, who manipulates liquidinjector 100, can also confirm the image around leak detection unit 431on liquid crystal display 103 when a leak warning is displayed on liquidcrystal display 103. Optionally, such an image may not be displayed atall times, but displayed only upon detection of a leaking liquid.

Further, while the foregoing embodiment has illustrated that liquidinjector 100 drives leak warning function 141 to notify a leak warningalone through image display on liquid crystal display 103, liquidinjector 100 can optionally display a measured time interval for eachpulse signal in a trend graph representation by a graph display means(not shown) through image display on liquid crystal display 103.

Since liquid injector 100 of the foregoing embodiment determines aleaking liquid when the difference between the last measured intervaland the currently measured interval exceeds an acceptable range, liquidinjector 100 may fail to determine a leaking liquid if the liquid leaksat an extremely low rate so that there is an imperceptible differencebetween the last and currently measured intervals, as shown in FIG. 16.

However, when the measured interval is represented by a trend graphdisplayed on liquid crystal display 103 as illustrated, the trend graphenables the operator to determine even a slow leak of a liquid.

Also, liquid injector 100 of the foregoing embodiment may experience atemporary erroneous detection even if the difference between the lastmeasured interval and the currently measured interval exceeds theacceptable range as shown in FIG. 17. However, the trend graph may bedisplayed as illustrated, permitting the operator to confirm even atemporary erroneous detection of a leaking liquid.

When liquid injector 100 detects the difference between wavelengths ofpulse signals instead of the difference between measured intervals asdescribed above, liquid injector 100 can likewise display the measuredwavelengths as represented by a trend graph, and can also display thedifference calculated from the measured intervals or measuredwavelengths as represented by a trend graph (neither shown).

Further, while the foregoing embodiment has illustrated that upondetection of a leaking liquid, liquid injector 100 stops piston drivingmechanism 113 to suspend the injection of a liquid, leak detection unit401 may comprise an independent tube blocking mechanism (not shown) forblocking extension tube 211 upon detection of a leaking liquid.

Such a tube blocking mechanism may be formed, for example, in anindependent modular structure mounted on extension tube 221 for makingwireless or wired communications with leak detection unit 401 and/ordetector body 101. The tube blocking mechanism may further has a featurefor opening/closing extension tube 211 with a driving source such as asolenoid which blocks extension tube 211 upon detection of a leakingliquid.

Since such a leak detector independently blocks extension tube 211 upondetection of a leaking liquid, liquid injector 100 can automaticallysuspend the injection of a liquid even if it is not associated with theleak detector.

Also, while the foregoing embodiment has illustrated that microprocessor130 functions in accordance with a computer program installed therein tologically implement a variety of functions 141-146 of injector body 101,at least some of various functions 141-144 may be formed in hardwaresuch as dedicated logic circuits.

Conversely, while the foregoing embodiment has illustrated that avariety of circuits 411-414 in leak detection unit 401 are formed ingiven hardware, the functions of circuits 411-414 may be logicallyimplemented, for example, by a microprocessor which runs in accordancewith a computer program installed therein.

Further, while the foregoing embodiment has illustrated that one liquidsyringe 200 is fitted in one recess 112 of liquid injector 100, aplurality of liquid syringes 200 may be fitted in a plurality ofrecesses of an injection head (not shown).

Also, the foregoing embodiment has illustrated that liquid syringe 200is directly fitted in liquid injector 100. However, since liquidsyringes 200 in a variety of sizes are commercially available atpresent, liquid syringe 200 of the largest size, for example, may onlybe fitted directly in liquid injector 100, while liquid syringes 200 ofvarious size except for the largest one may be fitted in liquid injector100 through respective dedicated cylinder adaptors (not shown).

1. A leak detector for detecting a leak of a liquid injected through aneedle into a blood vessel near the surface of a human body, comprisingpulse generating means for sequentially emitting pulse signals towardsaid human body at a position at which said needle is inserted throughwave propagation at a predetermined wavelength; pulse detecting meansfor detecting said pulses reflected inside of said human body;wavelength measuring means for measuring a wavelength for each of saiddetected pulse signals; difference calculating means for calculating thedifference between the measured wavelength and a predetermined referencewavelength; difference comparing means for comparing the calculateddifference with a predetermined acceptable range; and leak warning meansfor generating a leak warning for notification when the differenceexceeds the acceptable range.
 2. The leak detector according to claim 1,further comprising wavelength storing means for storing the measuredwavelength at least until the next wavelength is measured, wherein saiddifference calculating means calculates the difference between thecurrently measured wavelength and the last measured wavelength, saidlast measured wavelength being used as the reference wavelength.
 3. Theleak detector according to claim 1, further comprising wavelengthstoring means for storing a first measured wavelength, wherein saiddifference calculating means calculates the difference between the firstmeasured wavelength and the currently measured wavelength, said firstmeasured wavelength being used as the reference wavelength; and saiddifference comparing means compares the difference with a predeterminedacceptable range.
 4. The leak detector according to claim 1, furthercomprising graph display means for displaying the wavelength measuredfor each of said pulse signals in a trend graph representation.
 5. Theleak detector according to claim 1, further comprising graph displaymeans for displaying the difference calculated for each of said pulsesignals in a trend graph representation.
 6. The leak detector accordingto claim 1, wherein said pulse generating means emits said pulse signalscomprised of ultrasonic waves, and said pulse detecting means detectssaid ultrasonic pulse signals.
 7. The leak detector according to claim1, further comprising a leak detection unit having at least said pulsegenerating means and said pulse detecting means; and a replaceableprotection member for enclosing said leak detection unit, saidprotection member being transparent to the wave propagation.
 8. The leakdetector according to claim 1, wherein said leak detector comprises aplurality of said pulse generating means and/or a plurality of saidpulse detecting means.
 9. The leak detector according to claim 1,further comprising an extension tube for leading the liquid to saidneedle; and tube blocking means for blocking said extension tube whenthe difference exceeds the acceptable range.
 10. The leak detectoraccording to claim 1, further comprising imaging means for capturing animage of the human body at a position at which said needle is inserted;and image display means for displaying the captured image.
 11. The leakdetector according to claim 1, further comprising a leak detection unitincluding at least said pulse generating means and said pulse detectingmeans; a detector body formed separately from said leak detection unitand including at least said leak warning means, wherein said leakdetection unit further includes radio transmitting means fortransmitting a radio signal, and said detector body further includesradio receiving means for receiving the radio signal.
 12. The leakdetector according to claim 1, further comprising a leak detection unithaving at least said pulse generating means and said pulse detectingmeans; and a transparent adhesive pad for removably adhering said leakdetection unit on the surface of the human body, said adhesive pad beingmarked with a position of said needle.
 13. The leak detector accordingto claim 12, wherein said adhesive pad is replaceably formed separatelyfrom said leak detection unit; and said adhesive pad is additionallymarked with a position of said leak detection unit.
 14. The leakdetector according to claim 12, further comprising a replaceableprotection member formed integrally with said adhesive pad for enclosingsaid leak detection unit, said protection member being transparent tothe wave propagation.
 15. The leak detector according to claim 11,wherein said leak detection unit further includes imaging means forcapturing an image of the human body at a position at which said needleis inserted, and said detector body further includes image display meansfor displaying the captured image.
 16. The leak detector according toclaim 11, wherein said detector body further includes receptiondetecting means for detecting a receiving state of the radio signal; andstate notifying means for notifying the detected receiving state. 17.The leak detector according to claim 16, wherein said detector bodyfurther includes reception warning means for generating a receptionwarning for notification when the detected receiving state falls below apredetermined state.
 18. The leak detector according to claim 1, whereinsaid pulse generating means emits said pulse signals of infrared rays,and said pulse detecting means detects said infrared pulse signals. 19.The leak detector according to claim 18, further comprising an opticalfilter for passing the infrared rays exclusively at said wavelengththerethrough to said pulse detecting means.
 20. The leak detectoraccording to claim 18, wherein said pulse generating means emits saidpulse signals of infrared rays at a frequency which transmit through aparticular organ of the human body and is reflected by a particularorgan of the human body.
 21. The leak detector according to claim 20,wherein said pulse detecting means detects only the infrared rays atsaid wavelength.